Kornimate/medical-research-clean huggingface dataset:
stroke and cpap outcome study 3

Conditions: Ischemic Stroke; Intra Cerebral Hemorrhage; Obstructive Sleep Apnea; Adherence, Treatment; Motivation

Summary: a problem with breathing during sleep, called obstructive sleep apnea (osa), likely increases the risk of stroke and is common in people who have had a stroke, present in about 2/3 of stroke survivors. there is also evidence that osa predicts worse outcome after stroke. the question being addressed in the stroke and cpap outcome study 3 (scouts3) is how to improve use of continuous positive airway pressure (cpap) therapy to treat osa when started during intensive stroke rehabilitation.

in an initial single-arm study, participants with stroke will be tested for osa and treated with auto-titrating cpap during inpatient stroke rehabilitation and continued for a 3-month treatment period. multiple behavioral interventions will be used to improve cpap use, including intensive cpap technical support, motivational enhancement therapy, and phone and mobile health automated support. the multicomponent behavioral intervention will be optimized to improve cpap adherence with the engagement and input of stroke survivors.

Eligibility criteria:
inclusion criteria: * age 18 years or older * head ct or brain mri demonstrating an acute ischemic infarction or intraparenchymal hemorrhage within past 30 days * person providing consent (patient or legally authorized representative) able to be consented in english or spanish exclusion criteria: * unable to obtain informed consent from participant or surrogate * incarcerated * known pregnancy * current mechanical ventilation, tracheostomy or supplemental oxygen use \> 4l/min * current use of positive airway pressure or use within 14 days prior to stroke * history of pneumothorax, bullous emphysema or other serious co-morbid conditions which limit cpap use * stroke related to tumors, vascular malformations or subarachnoid hemorrhage * active use of sedative drugs that can interfere with testing for obstructive sleep apnea (osa) * anticipated inpatient rehabilitation length of stay \< 3 nights

Keywords: behavioral therapy continuous positive airway pressure rehabilitation therapy stroke recovery self determination
the effect of danhong injection on microcirculation in the treatment of patients with stemi after the ptca surgery.

Conditions: Myocardial Infarction

Summary: this study focused on the effect of danhong injection on microcirculation in the treatment of patients with stemi(st-elevation myocardical infarction) after the ptca surgery.

research topic. * a randomized, double-blind, placebo-controlled, multi-center clinical trial of the effect of danhong injection on microcirculation in the treatment of patients with stemi(st- elevation myocardical infarction) after the ptca surgery. research purpose. * this study focused on the effect of danhong injection on microcirculation in the treatment of patients with stemi(st-elevation myocardical infarction) after the ptca surgery. research design. * a randomized, double-blind, placebo-controlled, multi-center clinical trial.

Eligibility criteria:
inclusion criteria: * clinically definite or laboratory-supported diagnosis of stemi ,with the indication of ptca surgery. * 18≤age≤75; * agreed to join in the study and signed the inform consent form. exclusion criteria: * cardiogenic shock , killip iii-iv degree , papillary muscle rupture , septal perforation , episodes of ventricular tachycardia and ventricular fibrillation after electrical cardioversion , temporary pacemaker implanted avb iii degree. * past history of pci and cabg * acute or chronic infectious diseases(for example severe pneumonia); * recent history of hemorrhagic stroke(within six months) * combined with liver and kidney dysfunction; * history of valvular heart disease; * congenital heart disease or pulmonary hypertension; * all kinds of history of cardiomyopathy; * bleeding and other thrombotic diseases; * severe anemia , thrombocytopenia , other diseases of the blood system; * cancer , autoimmune disease , all kinds of the patients who use the glucocorticoid and immunosuppressor; * menstrual period women, pregnant women and lactating women, pregnancy test positive or recent family planning.
association between postoperative administration of l-arginine and csa-aki

Conditions: Acute Kidney Injury

Summary: to investigate the association between the the early administration of l-arginine after cpb-assisted cardiac surgery and the incidence of cs-aki in adult patients. to test if it can reduce the incidence of post-operative aki.


Eligibility criteria:
inclusion criteria: * adult patients (over 18 years) * underwent cpb assisted cardiac surgery * admitted to icu exclusion criteria: * congenital heart disease * underwent deep hypothermic circulatory arrest (dhca) * with glomerular filtration rate (egfr) below 30 ml/min/1.73 m²
xp13512 (gabapentin enacarbil) extension study in patients with restless legs syndrome.

Conditions: Restless Legs Syndrome

Summary: the primary objective of this trial is to assess the long-term safety and efficacy of xp13512 (gabapentin enacarbil) taken once daily for the treatment of patients suffering from restless legs syndrome (rls).

study xp055 is a multicenter, open-label, 52-week extension study of xp13512 (gabapentin enacarbil \[gen\]) given once daily to eligible subjects with restless legs syndrome (rls) who had previously completed 1 of the following studies and met eligibility criteria: xp052 (110963 \[nct00298623\]), xp053 (111460 \[nct00365352\]), xp081 (111462 \[nct01332305\]), and xp083 (111463 \[nct01332318\]).

Eligibility criteria:
inclusion criteria: * patients who have successfully completed one of the following studies: xp052 (110963 \[nct00298623\]), xp053 (111460 \[nct00365352\]), xp081 (111462 \[nct01332305\]), and xp083 (111463 \[nct01332318\]). exclusion criteria: * subjects who, in the opinion of the investigator, would be non-compliant with the study visit schedule, procedures, or medication administration.
mirage: multi-institutional research in alzheimer's genetic epidemiology

Conditions: Alzheimer's Disease

Summary: the goal of mirage is to evaluate the association of genetic and non-genetic risk factors for alzheimer's disease.

for the past 13 years the mirage project has demonstrated that genetic factors play a major role in the development of alzheimer's disease (ad) among patients ascertained in clinical settings. this research has also shown that the e4 variant of apolipoprotein e (apoe), is the strongest ad risk factor identified thus far. the researchers are turning their attention to the growing body of evidence from pathological, epidemiological and genetic studies that risk factors for vascular disease also enhance the risk of ad. however, since most epidemiological studies lack neuroimaging data, it is unclear whether the apparent association between vascular risk factors and ad is brought about by ischemic injury to the brain, acceleration of the primary alzheimer neurodegenerative process, or some other process. some vascular risk factors are more prevalent in african american and japanese american populations than in caucasians. this study will build upon earlier work by evaluating the association between apoe, genes involved in vascular function, and other indictors of cerebrovascular health including blood pressure and structural brain imaging (mri), and susceptibility to ad in these ethnic groups. in order to carry out this project successfully, a sample of 1000 patients (500 caucasians, 300 african americans, 200 japanese americans) who meet nincds/adrda criteria for probable or definite ad from 11 centers in the u.s., canada and germany will be recruited. many patients will be identified from the existing family registries. family history, medical history, and epidemiological information will be obtained from the ad patient and their first-degree relatives using standardized questionnaire instruments and established protocols. a cognitive screening test will be administered to and blood samples will be collected from the patient's living siblings, spouses and children over the age of 50 years. dna, plasma and mri of the brain will be evaluated in patients and siblings.

Eligibility criteria:
inclusion criteria: note: this trial accepts patients with probable ad, and their cognitively normal brothers or sisters * probable or definite ad by nincds-adrda criteria * living siblings who are cognitively normal as measured by a brief standardized cognitive assessment * ages 60 and over for alzheimer's disease patients * ages 50 and over for cognitively normal siblings exclusion criteria: * early onset alzheimer's disease attributed to app, ps1 or ps2 gene mutations * history of clinical stroke * siblings whose cognitive assessment does not meet study criteria * pacemaker or other contraindication to mri

Keywords: epidemiological study
presurgical therapy with lapatinib to explore molecular determinants of response to egfr/erbb2 targeted therapy

Conditions: Breast Cancer

Summary: the purpose of this study is to see what kinds of breast tumors will respond to lapatinib. lapatinib is an experimental medicine which may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.


Eligibility criteria:
inclusion criteria: * histologically or cytologically-confirmed by either core or fine needle biopsy primary invasive carcinoma of the breast; * ajcc t2-t3 disease (\>2.0 cm without chest wall or skin invasion) by at least one imaging modality (either mammogram, ultrasound, or mri) - entry criteria is based on radiologic staging and not final pathologic staging; * ecog performance status 0-1 (karnofsky ≥ 70% * any lymph node status, hormone receptor status, and level of erbb2 expression * no prior chemotherapy, hormonal therapy or radiation therapy to the affected breast for current or previous malignancy; * cardiac ejection fraction \>50% or within the institutional range of normal; * patients must have normal organ and marrow function defined as: leukocyte count \>3000/ul; absolute neutrophil count (anc) ≥ 1,500/mm3, platelets \> 100,000/mm3, and hemoglobin ≥ 8 gm/dl; serum creatinine ≤ 1.5 times uln, or 24-hour creatinine clearance ≥ 75 cc/min; serum bilirubin ≤ 1.5 times uln; sgot ≤ 2.5 times uln; alkaline phosphatase ≤ 2.5 uln times uln. * the effects of lapatinib on the developing human fetus at the recommended therapeutic dose are unknown. for this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately. * ability to understand and the willingness to sign written informed consent document. exclusion criteria: * ajcc t1, t4, or stage 4 disease; * patients may not have undergone incisional or excisional biopsy of their tumor; * patients may not be receiving any other investigational agents; * absolute contraindication to mri imaging (cardiac pacemaker or any non-removable metallic foreign object in the body); * on chronic therapy with any known inducer or inhibitor of cyp3a4 * uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * pregnant or lactating women are excluded from this study because lapatinib is a tyrosine kinase inhibitor with the potential for teratogenic or abortifacient effects.

Keywords: breast cancer tyrosine kinase inhibitors lapatinib biologic response modifiers magnetic resonance imaging treatment-naive, operable
effects of therapist behavior on the treatment of depressed adolescents

Conditions: Depression; Depressive Disorder; Dysthymic Disorder

Summary: the purpose of this study is to identify and evaluate therapist behaviors that affect how well and how long adolescent patients stay in treatment for depression.

early patient drop out, sporadic attendance, and minimal participation have hindered the development and administration of effective treatments for adolescent depression. adolescents who do not receive adequate exposure to active treatment are unlikely to benefit from experimentally supported treatments. certain therapist behaviors may influence the attendance, drop-out, and overall participation of adolescents with depression. this study will evaluate the effect of engagement interventions and alliance on attendance, participation, completion, and outcome in depressed adolescents. participants in this study will have 12 weekly sessions of cognitive behavioral therapy (cbt) at a school-based health clinic. audio recordings from the completed cbt sessions will be replayed and evaluated to identify therapist engagement interventions, therapy alliance, and treatment participation.

Eligibility criteria:
inclusion criteria: * major depression or dysthymic disorder * referred by school exclusion criteria: * comorbid psychosis, bipolar disorder, or mental retardation

Keywords: adolescent
bioactive lipids & pbmc

Conditions: Healthy

Summary: the investigators aim at harvesting pbmc from healthy donors to study the effect of the lipids mediators of interest. after isolation from the blood, pbmc will be activated as largely reported in the literature in the presence or absence of the tested lipids. the effect will be assessed by quantifying the expression of inflammatory markers. the expression of the receptors and enzymes potentially regulating the effects of the studied lipids will also be assessed.

data from the scientific literature support the hypothesis that bioactive lipids play an important role in inflammatory disorders. the levels of these bioactive lipids are altered in several pathophysiological conditions with an inflammatory component. the investigators and others have demonstrated that bioactive lipids affect the inflammatory tone in vivo in murine models as well as in in vitro models. however, confirming the translational value of these data is not easy in clinical studies. pbmc-based experiments are a powerful tool for us to validate our previous observations and will offer translational added value supporting further clinical investigations. thus, here the investigators aim at harvesting pbmc from healthy donors and use them to study the effect of the lipid mediators of interest (i.e. those showing interesting properties in our preclinical models). blood will be collected from healthy volunteers, and pmbc isolated based on their density. after isolation from the blood, pbmc will be activated as largely reported in the literature (e.g. using phytohemagglutinin or lipopolysaccharides) in the presence or absence of the tested lipids. the effect will be assessed by quantifying the expression of inflammatory markers (by rt-qpcr and/or elisa). the expression of the receptors and enzymes potentially regulating the effects of the studied lipids will be also assessed (by rt-qpcr).

Eligibility criteria:
inclusion criteria: * volunteers must be able to give informed consent to be included in the study. * no chronic inflammatory disease * no acute inflammation exclusion criteria: * men and women aged less than 18 years * pregnant women * prior diagnosis of a chronic inflammatory disease (for instance ibd, copd, lupus, ms, etc. this is not an exhaustive list). * recent (\<21 days) episode of acute inflammation or immune-altering event (e.g. cold, flu, vaccine, ...). * chronic or recent use of drugs interfering with the immune / inflammatory response. examples include (and are not limited to) nsaids, corticosteroids, aspirin, mabs, etc. * unable to give informed consent

Keywords: inflammation
c1q/tnf-related proteins in non-alcoholic fatty liver disease

Conditions: NAFLD

Summary: non-alcoholic fatty liver disease (nafld) is characterized by an accumulation of fat in the liver, which is one of the most common forms of chronic liver disease in developed countries. in western countries, the prevalence of nafld in the general population is estimated to be 20-30%; in obese populations, this increases to 57.5-74%. but, it hasn't been clearly elucidated yet regarding the underlying disease pathophysiology and treatmet strategy. recently, members of the c1q/tumor necrosis factor-related protein (ctrp) family have been reported to share structural homology with adiponectin. to date, 15 ctrp family members have been found that might play major roles in glucose metabolism and inflammation. the investigators tried to clarify the relationship between ctrp family and nafld in korean men and women.


Eligibility criteria:
inclusion criteria: * 20\<age\<80 * apparently healthy subjects exclusion criteria: * a history of cvd * diabetes * stage 2 hypertension * malignancy * severe renal or hepatic disease
effects of daytime eszopiclone administration in shift workers

Conditions: Shift-Work Sleep Disorder

Summary: the purpose of this study is to test the effects of eszopiclone on daytime sleep and overnight wakefulness in shift workers.

the current study seeks to extend the currently available treatments for swsd by addressing the putative root cause of the problem-the inability of night-shift workers with or without swsd- to obtain adequate daytime sleep in the face of the circadian drive for alertness that increases across the biological day. even healthy, young subjects who are sleep-deprived overnight exhibit daytime sleep marked by frequent awakenings and low sleep efficiency, less slow-wave sleep, and altered sleep architecture, e.g. earlier predominance of rem sleep. many night-workers routinely report 3-6 hours of habitual sleep duration for daytime sleep. pharmacological interventions to decrease awakenings and improve total sleep time during daytime sleep could improve subsequent alertness during a night shift. improving the wakefulness of night-shift workers over the nighttime could result in substantial benefits for the individual workers, improve workplace productivity and safety, and improve public health.

Eligibility criteria:
inclusion criteria: * age 20-50 (men or women) * current shift worker (for at least 3 months, at least 5 overnights/month and 3 consecutive) * a willingness and ability to comply with study procedures * if of child-bearing potential, using a medically-accepted method of birth control, including abstinence, barrier method with spermicide, steroidal contraceptive (oral, transdermal, implanted, or injected) in conjunction with a barrier method, or intrauterine device \[iud\]). exclusion criteria: * current diagnosis of dsm-iv axis i disorder (other than insomnia) * regular treatment (\>1time/wk) with cns-active medication within 1 month of first inpatient visit * uncontrolled medical illness that would interfere with participation in the study * bmi\>32 or \< 19.8 kg/m2 * current symptoms or diagnosis of any moderate to severe sleep disorder other than swsd * periodic leg movement of sleep index (plmsi)\>20/hr of sleep or respiratory desaturation index (rdi)\>15 on polysomnography (psg) * current alcohol or drug dependence/abuse * menopausal or peri-menopausal symptoms that disrupt sleep * pregnant, lactating, or planning to become pregnant * current smoking of more than 10 cigarettes per day * current use of over the counter sleep aids such as benadryl or melatonin

Keywords: shift-work swsd eszopiclone mwt shiftworkers
effect of tofogliflozin on uacr compared to metformin hydrochloride in diabetic kidney disease (truth-dkd)

Conditions: T2DM (Type 2 Diabetes Mellitus); Metformin; SGLT2-Inhibitors

Summary: this multicenter, randomized, open-label, controlled study will assess the efficacy of the sglt2 inhibitor tofogliflozin on urine albumin-to-creatinine ratio (uacr) compared to metformin in patients with type 2 diabetes with chronic kidney disease (ckd).

eligible participants will be randomly assigned (1:1) to tofogliflozin or metformin with stratification based on uacr (\<300 mg/gcr，≧300mg/gcr), an estimated glomerular filtration rate (egfr) (\<60ml/min/1.73m2, ≧60 ml/min/1.73m2), and age (\<65 years old, ≧65 years old). the primary end point is change in urine albumin-to-creatinine ratio (uacr) from baseline after 52 weeks treatment. changes in egfr, hba1c, body weight, systolic blood pressure, diastolic blood pressure, total serum proteins, serum albumin, uric acid, hematocrit, hemoglobin, red blood cell count, pulse rate, triglyceride, low-density lipoprotein, high-density lipoprotein and albuminuria class transition rate will also be evaluated.

Eligibility criteria:
inclusion criteria: * type 2 diabetic patients * patients aged 20 years or older at the time of obtaining consent * patients with hba1c 6.5 or more and 9.0% or less within 13 weeks before obtaining consent (evaluated by test values after 4 weeks or more without taking sglt2 inhibitor / metformin) * patients who have been judged by their doctor to need a diabetic drug when they are first seen, or who have already taken a diabetic drug and have decided that it is necessary to add one diabetic drug. * patients who have been receiving ras inhibitors (arb, arni, ace inhibitors, direct renin inhibitors) for 4 weeks or longer * patients with egfr of 30 or more (ml / min / 1.73m2) within 13 weeks before obtaining consent (evaluated by test values after 4 weeks or more without taking sglt2 inhibitor / metformin) * patients with urinary albumin / creatinine ratio (uacr) of 30 or more and less than 2000 (mg / gcr) (4 weeks or more without taking sglt2 inhibitor / metformin) within 13 weeks before obtaining consent evaluate by inspection value) * patients for whom written consent was obtained based on the patient's free will after receiving sufficient explanation for participation in this study exclusion criteria: * patients receiving treatment with sglt2 inhibitor or metformin within 13 weeks before obtaining consent * dialysis patient * patients with a history of severe hypoglycemia * patients with hypersensitivity to sglt2 inhibitor or metformin * pregnant women, lactating patients, and patients who wish to raise children * patients with bmi of 35 kg / m2 or more based on the latest measured values within 13 weeks before obtaining consent * patients who are contraindicated for the study drug * other patients who the attending physician deems inappropriate as a subject